Diagnostic CDMO Services
Developing high quality, resilient and scalable freeze dried and liquid formulations is vital for companies operating in the increasingly competitive global diagnostics industry. It is equally crucial that they launch these products to market as quickly and seamlessly as possible.
Biopharma Group provides a host of research and development (R&D), consultancy, and manufacturing services, which combine to enable you to swiftly produce robust and accurate products at scale. Through our versatile CDMO solutions, our expert scientific team can help you to reduce cold-chain logistics, optimise product performance, and extend the shelf life of your products.
Our end-to-end CDMO services support you throughout every step of your product’s development – from product assessment, proof of concept and formulation development to cycle development, troubleshooting, and scale up, technical transfer and manufacturing.
>> Read our Diagnostics CDMO Services Brochure
Why Choose Biopharma Group?
With over 35 years of freeze-drying experience, Biopharma Group is widely recognised as an industry leader in lyophilisation. Having completed over 4000+ projects across 30 countries, our team has the expertise, flexibility and capacity to meet your company’s specific requirements. Across these projects, our R&D services have delivered an average reduction of 80% in product storage costs for our customers, while decreasing their production costs by an average of 60%.
We were also a leading manufacturer of diagnostic tests for the UK’s National Health Service (NHS) throughout the COVID-19 pandemic. During which, we produced more than 2.5 million tests per month from 2020 to 2022.
By partnering with us, you can benefit from:
- Full intellectual property ownership (IP): Your organisation maintains full ownership of any products, processes, and IP created during the partnership. This provides you with complete autonomy over the project’s outputs and innovations, allowing you to implement these into your operations, audits, business strategy and brand identity.
- Assured compliance with IVDR: Our team has deep domain knowledge of in-vitro diagnostics for the point of care (PoC) sector. We provide expert advice and guidance on complying with the European Union’s In Vitro Diagnostics Regulation (IVDR), which is a required standard for all molecular diagnostics companies operating within the EU.
- Flexible production capacity: From one-off pilot-scale R&D work scopes to large-scale continuous production operations, our team has the agility and capacity to accommodate your project’s requirements.
- Secure worldwide shipping: We provide secure global shipping for all freeze-dried and liquid formulations. Our team can support a wide range of temperature levels – from -80°c to ambient temperatures.
- ISO accreditation: Biopharma Group is accredited to ISO 13485 and ISO 9001, ensuring full compliance with quality management regulations.
- Competitive pricing: Our CDMO diagnostics services are competitively priced, helping you to minimise your supply chain costs.
- Industry-leading innovation: Our scientific team was one of the industry’s leading innovators in lyobead technology. We continue to play an important role in evolving the technology to provide customers with accurate, fast, and cost-efficient lyobead generation services.
“Really successful collaboration – happy with services provided. Biopharma Group were attentive, responded quickly & provided a successful cycle!”
R&D Supervisor
ThermoFisher
“Thank you all, especially Niloo and Emma, for a super informative day! I really enjoyed getting to know your technology and was made to feel so welcome at your premises! It always makes for a great experience to see such passion for science and high quality services.”
N. Hudson, PhD
Principal Scientist
R&D / Analytical Services
- Product & Process Assessment
- Proof of Concept Studies
- Formulation Development
- Scale-up & Troubleshooting
- Tech Transfer to Production
Diagnostics Manufacturing
- Contract Freeze Drying for Lyocakes
- Lyobeads Technology
- Quality Control & ISO 13485 Compliance
- Packaging & Kitting Services
- Packing Service for Non-standard Products
Customer Testimonials
“We are very grateful for our collaboration with Biopharma Group and for their valuable help in the development of our lyophilization process. Their expertise and commitment played an important role in achieving results that exceeded our expectations. As a testament to our joint effort, we launched our first lyo-compatible qPCR mix - SolisFAST® Lyo- Ready qPCR Kit with UNG. We appreciate their genuine dedication to our project and look forward to continued success together.”
“Through my experience of working with Biopharma Group on various lyo projects, I can happily say that I have always been super impressed with the results that we have received! We will definitely continue to make Biopharma Group our first choice when needing to outsource freeze drying support.”
We have had the opportunity to work with Biopharma Group on several projects to optimize and improve freeze-drying processes. Biopharma Group has real expertise that is put to the benefit of its customers. The responsiveness of their teams and the tools used have always been highly appreciated.
We worked with Biopharma group very intensively around Lyo project development. I was very much impressed and enjoyed working with the team that provided detailed, and regular updates on project progress, challenges, and solutions.
The information provided by the Biopharma Group team helped me to improve the quality of our product, and in particular helped me to develop more effective and efficient processes for transferring our products from research to the production stage.
Theragenix has benefited from Biopharma Group services to develop a formulation suitable for lyophilisation. The project involved a freeze drying cycle and a series of analyses for stability studies. Both technical and commercial support has been very appreciated
“Thank you for being so professional, helpful, innovative and friendly. We were extremely impressed with the quality of your service.”
“We elected to work with Biopharma because of their full service and years of experience. They helped us with analysis and troubleshooting of our product and we were impressed by the quality and responsiveness of their scientists. We would definitely use them again.”
“Biopharma developed a successful cycle for us, their quality and technical support was excellent.”
“Biopharma helped develop our cycle, we are extremely satisfied with their quality and service and would thoroughly recommend them to others.”
“Biopharma Group quickly understood our radiopharmaceutical challenges and provided effective solutions. Their team is highly responsive, knowledgeable, and a pleasure to work with.”
“We chose Biopharma because of their reputation and expertise in the field of lyophilisation and we were impressed with their overall excellent level of service. We would recommend them.”
"Biopharma Group always offered fast and reliable results in our Freeze Dry Microscopy studies. Big thanks for a great team!"
“We worked with Biopharma Group for the development and deployment of an antibody freeze drying process to support preclinical studies. They rapidly provided technical insights to guide the design of the process development study and helped troubleshoot unexpected results. The team’s experience was critical to the success of this project, and we benefitted from an open and collaborative approach throughout.”
